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Trial record 78 of 236 for:    PRASTERONE

Effects of Dehydroepiandrosterone (DHEA) in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182975
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 25, 2008
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.

Condition or disease Intervention/treatment Phase
Aging Drug: DHEA replacement Phase 3

Detailed Description:

DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also appears to have anabolic effects on muscle and bone. The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being.

The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will (a) Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve general sense of well being.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Is DHEA Replacement Beneficial?
Study Start Date : September 2002
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength

Secondary Outcome Measures :
  1. bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 65 to 75 years old
  • Physically healthy
  • Non-smoker
  • On stable medications for at least 6 months
  • Stable body weight for the past year

Exclusion Criteria:

  • Serious active medical problems
  • Hormone therapy
  • Abnormal PSA (prostate specific antigen) in men

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182975

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: John O. Holloszy, MD Washington University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00182975    
Other Study ID Numbers: AG0047
R01AG020076 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008
Keywords provided by National Institute on Aging (NIA):
Metabolic syndrome
Additional relevant MeSH terms:
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Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs